Full Press Release Details
FDA Approves ASCENIV , a Novel
Intravenous Immune Globulin
RAMSEY, N.J. and BOCA RATON, FL., - April 1, 2019 -
ADMA Biologics, Inc. (NASDAQ: ADMA) ("ADMA" or the "Company"), a vertically integrated commercial biopharmaceutical
and specialty immunoglobulin company that manufactures, markets and develops plasma-derived biologics for the treatment of immune
deficiencies and the prevention of certain infectious diseases, announces that the U.S. Food and Drug Administration ("FDA")
has approved ASCENIV , Immune Globulin Intravenous, Human - slra 10% Liquid, formerly referred to as RI-002. ASCENIV
is an Intravenous Immune Globulin ("IVIG") drug product for the treatment of Primary Humoral Immunodeficiency Disease
("PIDD" or "PI") in adults and adolescents (12 to 17 years of age). The Company anticipates having the
product available for commercial launch during the second half of 2019.
The ASCENIV pivotal Phase III clinical study followed
FDA guidance for treatment of patients with PI. The study enrolled fifty-nine patients with PI at nine sites across the U.S. in
which study patients received regular infusions of ASCENIV over the course of one year. The trial's primary endpoint
evaluated the rate of Serious Bacterial Infections ("SBI") in patients treated with ASCENIV . Secondary endpoints
included time to first SBI and to first serious infection, days on antibiotics, days off school or work due to infections, all
confirmed infections of any kind, and hospitalizations due to infection. There were zero SBIs during the 12-month study period.
The manuscript and data set describing the results are published by Dr. Richard Wasserman, et al in the Journal of Clinical Immunology
(2016) Volume 36: 590-599. The approved labeling will include a boxed warning about potential thrombosis and renal dysfunction
or failure, as well as the most common adverse events observed in the pivotal study, which were headache, sinusitis, diarrhea,
gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea.
"We are excited about this significant achievement in
receiving FDA approval for ASCENIV a novel, patented IVIG product that we feel is a necessary addition to existing available
therapies for patients who suffer from PI. We hope availability of ASCENIV will help ameliorate a portion of the current
shortages facing U.S. IVIG supply," stated Adam Grossman, President and CEO of ADMA Biologics. "There are approximately
250,000 PI patients diagnosed and living in the U.S., and we believe there is an opportunity to treat meaningful segments of this
patient population with ASCENIV . As previously disclosed, ASCENIV is manufactured using our unique, patented plasma
donor screening methodology and tailored plasma pooling design, which blends normal source plasma and plasma from donors tested
using our proprietary microneutralization assay. Going forward, we believe this FDA approval better positions ADMA to further its
mission to evaluate ASCENIV in immune-compromised patients infected with or at-risk for Respiratory Syncytial Virus ("RSV")
infection. We look forward to working with the FDA and the immunology and infectious disease community on developing a clinical
investigation to evaluate use of ASCENIV in this patient population in the near future."
Mr. Grossman continued, "We are grateful to the clinical
trial subjects, investigators, and health care workers who participated in our Phase III trial and thank them for their extraordinary
efforts. We are also thankful to our dedicated and loyal employees who relentlessly contributed to the approval of ASCENIV
and exemplify our corporate mission of working tirelessly because patients are counting on us."
"With the receipt of ASCENIV's FDA approval,
ADMA, at its sole option, can elect to access up to an additional $27.5M of available funding from Perceptive Advisors under ADMA's
existing credit facility. This option remains available to the Company through June 2020, and such funds could be used to support
the launch of ASCENIV , procure plasma raw material inventory, and begin construction on potential new plasma centers, as
well as for general corporate activities," concluded Mr. Grossman.
Any medical or scientific questions regarding ASCENIV
or any other product produced by ADMA Biologics should be directed to the Company's medical information department by calling
800-458-4244 or emailing to MA@admabio.com.
ADMA Biologics, Inc. (ADMA)
ADMA Biologics is a vertically integrated commercial biopharmaceutical company that manufactures, markets and develops specialty
plasma-based biologics for the treatment of Primary Immune Deficiency Disease ("PIDD" or "PI") and the
prevention and treatment of certain infectious diseases. ADMA's mission is to develop and commercialize plasma-derived, human immune
globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases. The target patient
populations include immune-compromised individuals who suffer from an underlying immune deficiency disease, or who may be immune-compromised
for other medical reasons. ADMA has received U.S. Patents 9,107,906, 9,714,283, 9,815,886 and 9,969,793 related to certain aspects
of its products. For more information, please visit www.admabiologics.com.
About ASCENIV (Formerly referred to as RI-002)
ASCENIV , Immune Globulin Intravenous, Human -
slra 10% Liquid, is a plasma-derived, polyclonal, intravenous immune globulin ("IVIG"). ASCENIV is protected
by U.S. Patents: 9,107,906, 9,714,283 and 9,815,886. ASCENIV is manufactured using our unique, patented plasma donor screening
methodology and tailored plasma pooling design, which blends normal source plasma and plasma from donors tested using our proprietary
microneutralization assay. ASCENIV contains naturally occurring polyclonal antibodies. ASCENIV is indicated for
the treatment of Primary Humoral Immunodeficiency ("PI") in adults and adolescents (12 to 17 years of age). ADMA received
FDA approval for ASCENIV on April 1, 2019. Polyclonal antibodies are proteins that are used by the body's immune system
to neutralize microbes, such as bacteria and viruses and prevent against infection and disease. ASCENIV prevented serious
bacterial infection among fifty-nine patients treated for twelve months during the pivotal investigation. The most common adverse
reactions to ASCENIV ( 5% of study subjects) were headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis,
upper respiratory tract infection, bronchitis, and nausea. ADMA anticipates the commercial launch of ASCENIV during the
second half of 2019. Certain data and other information about ASCENIV or ADMA Biologics and its products can be found on
the Company website at: www.admabiologics.com.
Additional Important Safety Information about ASCENIV
ASCENIV (immune globulin intravenous, human - slra)
is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI)
in adults and adolescents (12 to 17 years of age). PI includes, but is not limited to, the humoral immune defect in congenital
agammaglobulinemia, common variable immunodeficiency (CVID), X linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe
combined immunodeficiencies (SCID).
WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
Thrombosis may occur with immune globulin (IGIV) products,
including ASCENIVTM. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history
of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk
factors. Thrombosis may occur in the absence of known risk factors.
Renal dysfunction, acute renal failure, osmotic nephrosis,
and death may occur with the administration of IGIV products in predisposed patients.
Renal dysfunction and acute renal failure occur more commonly
in patients receiving IGIV products containing sucrose. ASCENIVTM does not contain sucrose.
For patients at risk of thrombosis, renal dysfunction or
renal failure, administer ASCENIVTM at the minimum dose and infusion rate practicable. Ensure adequate hydration in
patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for
ASCENIV is contraindicated in:
Warnings and Precautions
Severe hypersensitivity reactions may occur with IGIV products,
including ASCENIV . In case of hypersensitivity, discontinue ASCENIV infusion immediately and institute appropriate
treatment. Medications such as epinephrine should be available for treatment of acute hypersensitivity reactions.
Thrombosis may occur following treatment with immunoglobulin
products, including ASCENIV . Thrombosis may occur in the absence of known risk factors.
Acute renal dysfunction/failure, osmotic nephrosis, and death
may occur upon use of human IGIV products. Ensure that patients are not volume depleted before administering ASCENIV . Periodic
monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing
acute renal failure.
Hyperproteinemia, increased serum viscosity, and hyponatremia
may occur in patients receiving IGIV treatment, including ASCENIV .
Aseptic meningitis syndrome (AMS) may occur with IGIV treatments,
including ASCENIV . AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV.
IGIV products, including ASCENIV , may contain blood group
antibodies that can act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, causing a positive